Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer

This study has been completed.
Sponsor:
Collaborator:
Taiho Pharmaceutical Co., Ltd.
Information provided by:
Japan Clinical Cancer Research Organization
ClinicalTrials.gov Identifier:
NCT00639327
First received: March 5, 2008
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced gastric cancer.


Condition Intervention Phase
Gastric Cancer
Drug: S-1 + irinotecan
Drug: irinotecan
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II/III Trial of Second Line Chemotherapy Comparing CPT-11 Monotherapy Versus S-1/CPT-11 Combination for S-1 Refractory Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Japan Clinical Cancer Research Organization:

Primary Outcome Measures:
  • In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet. [ Time Frame: Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events, response rates, progression free survival, time to treatment failure, change over rates to 3rd line [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: March 2008
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
CPT-11+ S-1
Drug: S-1 + irinotecan
Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD
Other Names:
  • TS-1
  • CPT-11
Active Comparator: B
CPT-11
Drug: irinotecan
Irinotecan 150mg/m2 iv on day one every two weeks until PD
Other Name: CPT-11

Detailed Description:

Standard chemotherapy for advanced gastric cancer (AGC) in the US is Cisplatin/5-FU (CF) or docetaxel/CF (DCF), is in Europe epirubicin/CF (ECF) or epirubicin/oxaliplatin/ capecitabine (EOX). Until 2006, there was no evidence of standard chemotherapy for AGC in Japan. In 2007, by the results of JCOG9912 trial (5-FU alone vs. CPT-11/CDDP vs S-1) and SPIRITS trial (S-1 alone vs. S-1/CDDP), S-1/CDDP is regarded as a new standard regimen in Japan. In 2008, by the results of TOP-002 trial (s-1 alone vs. S-1/CPT-11), S-1/CPT-11 could not show the superiority to S-1 alone. One of the other phase III trials, JACCRO GC-03 trial (S-1 alone vs. S-1/docetaxel, NCT00287768) is now ongoing. However, the position of CPT-11 in the treatment of AGC will be regarded as a second-line.

In Japan there is a controversy for the treatment of S-1 refractory gastric cancer. The controversy is continuing S-1 (like FOLFOX to FOLFIRI) or not as a second-line. After the successful adjuvant S-1 results (ACTS-GC trial), the same problem will occur in the patients who are recurrent from adjuvant S-1.

Then, we conducted a phase II/III trial of CPT-11 with or without S-1 in the treatment of first-line S-1 refractory AGC.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) or relapse gastric adenocarcinoma
  • Subjects must be able to take orally
  • Subjects must be confirmed to be PD status by picture diagnosis after first-line chemotherapy using S-1 alone, S-1 + Cisplatinum or S-1 + taxane, except S-1 + CPT-11
  • Within 4 weeks from the diagnosis of PD
  • Total dosage of S-1 at the first-line is over 2,240mg/m2 in S-1 alone treatment, 1,680mg/m2 in the S-1 combination
  • ECOG performance status ≤ 1
  • Follow up Age 20 or over
  • Life expectancy estimated more than 12 weeks
  • Hgb ≥ 8 g/dL, WBC 4,000-12,000/mm3, ANC ≥ 2,000/mm3, platelets ≥ 100,000/mm3
  • Creatinine ≤ upper normal limit (UNL)
  • Total bilirubin ≤ 1.5 X UNL
  • Written informed consent

Exclusion Criteria:

  • S-1 + CPT-11 was employed as a first-line
  • Any other cytotoxic agents therapy, immuno-therapy, radiation-therapy
  • After S-1 adjuvant
  • Suspended cases by adverse events by S-1 or S-1 combination
  • Excessive amounts of ascites require drainage
  • Known brain metastases
  • History of hypersensitivity to fluoropyrimidines and CPT-11
  • Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
  • Active double cancer
  • Gastrointestinal bleeding
  • Any subject judged by the investigator to be unfit for any reason to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639327

  Show 86 Study Locations
Sponsors and Collaborators
Japan Clinical Cancer Research Organization
Taiho Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Masashi Fujii, M.D.,PhD Surugadai Nihon University Hospital
  More Information

No publications provided

Responsible Party: Masashi Fujii/Associate Professor, Department of Digestive Surgery, Surugadai Nihon University Hospital
ClinicalTrials.gov Identifier: NCT00639327     History of Changes
Other Study ID Numbers: JACCRO GC-05
Study First Received: March 5, 2008
Last Updated: June 27, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Cancer Research Organization:
Stomach Neoplasms
Second line chemotherapy
Refractory to S-1
irinotecan
S-1 and Irinotecan Combination
Phase III study

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Camptothecin
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014